Clinical Research Question of the Month: January 2018

In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.

This month’s question:

You are a member of the board at Florida Central IRB. You are reviewing a vaccine study for Zika2, a deadly infectious disease that has recently emerged in Florida and is spreading fast. The only clinical study discussed in the Investigator’s Brochure was conducted in Brazil, where Zika2 originated. It provides scientifically sound evidence that supports the proposed study. However, you have just learned that, because of the emergency situation in Brazil, the investigators made the decision to conduct their study without regulatory or ethics committee approval, in a vulnerable population, and without informed consent. The Brazilian manufacturer and investigators will not be involved in the proposed study. Time is of the essence.

Will you vote to approve the study? Would your decision change if you knew no Brazilian study participants had been harmed? For these and further questions, take the survey here.

Last month’s question posed readers with a situation in which they had to decide whether or not to approve a study of a treatment developed to restore zombies to normal health in the midst of a zombie apocalypse. Most were in favor of approving the study; 42% of respondents voted to approve and 29% voted to approve provided that competent representatives give consent on behalf of the subjects. Only 6% of participants rejected the study entirely. Respondents were divided on whether or not zombies are covered by human subjects regulations, with 52% saying no. You can find the full report here.

The Question of the Month also appears on the IRB Forum. The IRB Forum is a robust community of IRB professionals engaged in an ongoing discussion of the latest issues and questions that arise for human subjects protections professionals. An account is free, and gives you access to an invaluable resource—the insight of your peers.

PRIM&R thanks Norm Goldfarb of First Clinical Research for allowing us to share this feature with our community!